CD Horizon Spinal System— 510(k) K221244
Substantially EquivalentMedtronic
FDA 510(k) clearance K221244 for CD Horizon Spinal System, Substantially Equivalent on 2022-05-25. Applicant: Medtronic. Device class: 2.
Clearance details
- Applicant
- Medtronic
- Product code
- Code NKB
- Device class
- Class 2
- Regulation
- 21 CFR 888.3070
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Memphis, TN, US
Recent devices under product code NKB
view all- K262828 — KHEIRON® Spinal Fixation System, including patient specific K-ROD
- K253943 — Tiger 2 System
- K260362 — QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)
- K261284 — Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System
- K253802 — KHEIRON® Spinal Fixation System, including patient specific K-ROD
More clearances from Medtronic
view all- K253530 — Trexon Monofilament Synthetic Absorbable Suture
- K251744 — Affinity Pixie Arterial Filter with Balance Biosurface; Affinity® Pediatric Arterial Blood Filter
- K233433 — Sphere-9Dx Diagnostic Catheter (AFR-00009)
- K240190 — MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System Uncoated
- K223494 — CD Horizon Spinal System
Adverse events under product code NKB
product code NKB- Death
- 27
- Injury
- 5,033
- Malfunction
- 4,140
- Total
- 9,200
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.